Highlights & Summary
Liquid Biopsy (LBx) continued to develop through May, featuring an abundance of FDA approvals and research partnerships.
Clinical & Regulatory
Foundation Medicine’s FoundationOne Liquid CDx received FDA-approval as a companion diagnostic for EXKIVITY, a therapeutic for patients with NSCLC that is EGFR exon-insertion 20 positive.This approval aids treatment access to patients with this unique disease, which often requires highly targeted treatment due to its rarity. The FDA provided a premarket approval for Tempus’ xt CDx, a companion diagnostic that evaluates over 600 genes, including microsatellite instability for status for some patients. Nucleix’s Bladder EpiCheck received 510(k) clearance from the FDA for use as a non-invasive surveillance method for patients who have previously been diagnosed with non-muscle invasive bladder cancer. The test is commercially available in Europe. The FDA granted breakthrough device status to Singlera Genomics’ PDACatch liquid biopsy assay, which works to identify pancreatic adenocarcinoma in high-risk populations; the FDA also granted de novo requests for the marketing of two of QuidelOrtho’s COVID-19 serology tests.
1 | FoundationOne®Liquid CDx Receives FDA-Approval as a Companion Diagnostic for EXKIVITY® (mobocertinib) to Identify Patients with EGFR Exon 20 Insertion Mutations in Advanced Non-Small Cell Lung Cancer FDA-Approval CDx | FoundationOne
2| Tempus Receives U.S. FDA Approval for xT CDx, a NGS-Based In Vitro Diagnostic Device FDA Approval CDx | Tempus
3 | Nucleix’s Bladder EpiCheck® Receives FDA 510(k) Clearance for Monitoring of Non-Muscle Invasive Bladder Cancer (NMIBC) Recurrence FDA 510(k) Clearance | Nucleix
Company Announcements & Product Launches
Aspira Women’s Health announced it signed an exclusive licensing agreement with Dana Farber Cancer Institute for the design and development of a new non-invasive miRNA-based ovarian cancer diagnostic tool for women with adnexal masses. Menarini Silicon Biosystems signed a partnership with Alivio Health to expand access to CELLSEARCH liquid biopsy tests which enumerates circulating tumor cells (CTCs) for metastatic breast, prostate, and colorectal cancer. Micronoma is also collaborating with New York University researchers to identify microbial and host genomic signatures that can be used to detect NSCLC in early stages or predict post-surgical recurrence.
1 | Aspira Women's Health Signs an Exclusive Licensing Agreement with Dana Farber Cancer Institute for the Development of microRNA-based Ovarian Cancer Test Exclusive Licensing Agreement | Aspira Women’s Health, Dana-Farber Cancer Institute
2 | New Menarini Silicon Biosystems partnership with Alivio Health expands patient access to CELLSEARCH® liquid biopsy tests Company Partnership | Menarini Silicon Biosystems, Alivio Health
3 | Micronoma Teams Up with NYU Grossman School of Medicine on Lung Cancer Research Grant Utilizing Microbial Biomarkers Company Collaboration | Micronoma, NYU Grossman School of Medicine
Clinical Trials & Study Results
Personalis announced a partnership with the Academic Breast Cancer Consortium (ABRCC) and Criterium to conduct a prospective clinical trial, B-STRONGER-1 to evaluate NeXT Personal, its MRD and monitoring assay, in early-stage TNBC. Personalis also announced a collaboration with National Cancer Center Hospital East (NCCHE) and Ono Pharmaceutical to examine the efficacy of nivolumab in rectal cancer using NeXT Personal on plasma and ImmunoID NeXT on tumor samples. Outside of industry, researchers from Stanford University published a study on a strategy for using nanopore-based single-molecule sequencing to measure cfDNA methylomes and a team at Purdue University presented a liquid biopsy technique that may identify signs of Parkinson’s disease in urine samples.
1 | Personalis, ABRCC, and Criterium Announce Major Prospective Clinical Trial for Residual and Recurrent Disease Detection in Triple Negative Breast Cancer Clinical Trial Announcement | Personalis, ABRCC, Criterium
2 | Personalis, National Cancer Center Hospital East, and Ono Collaborate to Better Predict Immunotherapy Response for Rectal Cancer Clinical Trial Collaboration | Personalis, National Cancer Center Hospital East, Ono
3 | Single-Molecule Methylation Profiles of Cell-Free DNA in Cancer with Nanopore Sequencing Study Result | Stanford School of Medicine, Stanford University
M&A | VC | Private Equity | Legal
A jury in the U.S. District Court for the District of Delaware voted in favor of Natera in the patent infringement suit filed against ArcherDX / Invitae Corp. The jury awarded $19.35 million to be paid by defendants to Natera. Illumina shareholders voted for the replacement of John W. Thompson, who had served on Illumina’s board since 2017, by Andrew J. Teno. A new chair is expected to be elected in coming weeks, though shareholders voted to reelect eight directors endorsed by Illumina.
1 | Jury Rules in Favor of Natera, Finding all Asserted Patents Valid and Infringed by ArcherDX/Invitae; Awards $19.35 Million in Past Damages for Royalties and Lost Profits Verdict Results | Natera, ArcherDx
2 | Illumina Shareholders Elect Ally of Icahn to Board, Ousting Chairman Board Election | Illumina
Additional Sources
Clinical & Regulatory
1 | Guardant Health Secures Coverage From Major US Commercial Health Insurers for Guardant360® Blood Test for Comprehensive Genomic Profiling Commercial Health Coverage | Guardant Health
2 | FDA grants breakthrough device status to Singlera's liquid biopsy assay FDA Breakthrough Device Designation | Singlera
3 | FDA grants de novo request enabling the marketing of QuidelOrtho SARS-CoV-2 antibody tests FDA Marketing Authorization | QuidelOrtho
Company Announcements & Product Launches
1 | BostonGene and Australia’s Mater Research Collaborate in New Follicular Lymphoma Study Company Collaboration | BostonGene, Mater Research
Clinical Trials & Study Results
1 New liquid biopsy method offers potential for noninvasive Parkinson’s disease testing Study Result - New LBx Technique | Purdue University, Tymora Analytical Operations
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